HELIOMAT— 510(k) K802684
Substantially EquivalentVivadent (Usa), Inc.
FDA 510(k) clearance K802684 for HELIOMAT, Substantially Equivalent on 1980-11-24. Applicant: Vivadent (Usa), Inc.. Device class: 1.
Clearance details
- Applicant
- Vivadent (Usa), Inc.
- Product code
- Code EAY
- Device class
- Class 1
- Regulation
- 21 CFR 872.4620
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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